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Regulatory Submissions, Information, and Document Management Forum

Session 5 Track 3: Managing eTMF System Access: How SAFE-BioPharma Certified Credentials Enable Secure Identity Management

Session Chair(s)

Cindy  Chiu

Cindy Chiu

  • Senior Director, Regulatory Affairs Operations and Quality Management
  • Merck & Co., Inc., United States
One of the largest pharmaceutical companies in the world has been a leader in the adoption and use of SAFE-BioPharma certified credentials for digital signing and identity management. After adopting a cloud-based eTMF, security and access through robust identity management was critical to maintaining protection of proprietary and sensitive documentation. The use of the existing credentials for company employees was an obvious transition to develop the use case for accessing the eTMF.


Betsy  Fallen, RN

Overview of the Identity Authentication Credential: What Does it Mean for Security in the Cloud?

Betsy Fallen, RN

  • Consultant
  • BAFallen Consulting LLC, United States
Cathy  Carfagno

Process of Adopting the Use of SAFE-BioPharma Credentials and How the Management of Those Credentials is Executed to be Efficient, Compliant, and Timely

Cathy Carfagno

  • Associate Director Merck IT
  • Merck & Company Inc., United States
Todd  Tullis

eTMF Platform Identity Management

Todd Tullis

  • Product Manager
  • Veeva, United States